510(k) K202916
K202916 is an FDA 510(k) premarket notification submitted by Shanghai Heartcare Medical Technology Co., Ltd. for the device "Balloon Guiding Catheter". The FDA issued a decision of Substantially Equivalent on August 25, 2021. The device falls under product code QJP (Catheter, Percutaneous, Neurovasculature), a Class II device regulated under 21 CFR 870.1250. Shanghai Heartcare Medical Technology Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 25, 2021
- Date Received
- September 29, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous, Neurovasculature
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- NE
- Submission Type
To provide vascular access to the neurovasculature for interventional or diagnostic procedures